Validation Protocol and Report Procedure | ISO 13485 | FDA QMSR

Structure medical device validation protocols and final reports with this editable ISO 13485 procedure. It covers the content of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Product Performance Qualification (PPQ) documents, including results, deviations, approval and record control.

The Validation Protocol and Report Procedure instructs on the development of Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Performance Qualification (PQ) Protocols and Product Performance Qualification (PPQ) Protocols. The Validation Protocol and Report Procedure also provides instruction on the format and required content of all validation final reports.

• IQ, OQ, PQ and PPQ protocol content

• Qualification report structure and results

• Deviation, approval and document-control requirements

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

Pair this document with the Process Validation Procedure for overall planning and the Installation Qualification Procedure for equipment installation activity.

Supplied as an editable Microsoft Word document as a digital download.

Part of a procedure bundle

This document is also included in ISO 13485 Process Validation Procedure Bundle. Explore the bundle for the related documents.